BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAR INSTRUMENTS KIT STERILE PACKAGED

    MDR report key: 5230888 · Received November 17, 2015

    Report

    Report Number
    0008031020-2015-00457
    Event Type
    Malfunction
    Date Received
    November 17, 2015
    Date of Event
    October 22, 2015
    Report Date
    October 22, 2015
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION REVEALED THE ANTERIOR CHAMFER REAMER TO BE THE PRIMARY PRODUCT. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE HELICAL MATERIAL ABRASION AND DEFORMATION OF THE SLEEVE, REAMER SHAFT AND E-RING INDICATE THAT THE REAMER WAS OPERATED WITHIN THE CUTTING GUIDE SLOTS WITH HEAVY BENDING FORCES TOWARDS SUPERIOR AND INFERIOR; THESE MASSIVE DAMAGES/DEFORMATIONS/ABRASIONS COMPARED WITH THE DAMAGES FOUND ON THE CUTTING EDGES AND TIP INDICATE THAT THE REAMER WAS USED MOST LIKELY IN SEVERAL SURGERIES. THE MATERIAL OF THE SLEEVE WAS DEFORMED IN THAT WAY THAT THE LENGTH GOT INCREASED. DUE TO THE INCREASED LENGTH THE E-RING WAS PUSHED OUT OF ITS CIRCUMFERENTIAL GROOVE AND WAS FREE MOVABLE ON THE REAMER SHAFT. AT THIS POINT THE SLEEVE WAS NO LONGER SECURED AND WAS ALSO AXIALLY MOVEABLE. WITHOUT A SECURED SLEEVE THE REAMER WILL NO LONGER STOP AT ITS REQUIRED DEPTH AND A DEEPER REAMING INTO THE TALUS BONE IS POSSIBLE. THE IFU INCLUDES THAT THE INSTRUMENTS SHALL BE PRE-CHECKED BEFORE EVERY SURGERY REGARDING DAMAGES/DEFORMATIONS; FURTHERMORE INSTRUMENTS SHALL BE USED WITH CARE. ADDITIONALLY THE REAMER IS LABEL-MARKED AS SINGLE USE PRODUCT; A MULTIPLE-USAGE IS NOT ALLOWED. THE CASE IS ATTRIBUTED AS USER MISUSE, NO NON-CONFORMITY WAS DETECTED.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY SMALL BONE INNOVATION, INC., (B)(6), HOWMEDICA OSTEONICS CORP.¿S PURCHASED CERTAIN ASSETS OF SBI ON (B)(6) 2014. STRYKER BECAME LEGAL MANUFACTURER OF THIS PRODUCT ON (B)(6) 2015 AND HAS TAKEN THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE WHILE PREPARING THE ANTERIOR SURFACE OF THE TALUS WITH THE REAMER 100-3007 THE BEARING MECHANISM ON THE DEVICE BECAME DETACHED AND WAS MOVING FREELY ON THE SHAFT. THIS ALLOWED THE SURGEON TO REAM TO MORE DEPTH THAN NECESSARY. ONCE THIS WAS NOTICED WE CHANGED TO ANOTHER BACKUP REAMER FROM THE INSTRUMENT SET AND FINISHED THE PREPARATION WITHOUT ISSUE. SALES REP CLARIFIED THAT THE REAMER CAME OUT OF STAR INSTRUMENTS KIT, STERILE PACKAGED (CAT: 100-0071/LOT: 20320). ONLY THE REAMER HAS AN ISSUE. EVENT OCCURED DURING PRIMARY SURGERY.

    Description of Event or Problem · 1

    DURING THE PROCEDURE WHILE PREPARING THE ANTERIOR SURFACE OF THE TALUS WITH THE REAMER 100-3007 THE BEARING MECHANISM ON THE DEVICE BECAME DETACHED AND WAS MOVING FREELY ON THE SHAFT. THIS ALLOWED THE SURGEON TO REAM TO MORE DEPTH THAN NECESSARY. ONCE THIS WAS NOTICED WE CHANGED TO ANOTHER BACKUP REAMER FROM THE INSTRUMENT SET AND FINISHED THE PREPARATION WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760830 STAR INSTRUMENTS KIT STERILE PACKAGED PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME NTG STRYKER GMBH 20320

    Patients

    Seq Age Sex Outcome Treatment
    1 Other